General Information of Synthetic Binding Protein (SBP) (ID: SBP000003)
SBP Name
Monobody Talditercept alfa
Synonyms
Taldefgrobep alfa; BMS-986089; RO-7239361; RO7239361; RG6206
Molecular Weight 75.6 kDa
Design Method Traditional methods (Site-directed mutagenesis and/or Directed evolution)
Highest Status Phase III
Sequence Length 340
SBP Sequence
>Monobody Talditercept alfa
DKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVD
GVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIKTISKAKG
QPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSD
GSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPELQLEESAAEAQEGEL
EGVSDVPRDLEVVAATPTSLLISWTLPHAGRAHYYRITYGETGGNSPVQEFTVPGRGVTA
TISGLKPGVDYTITVYAVTVTTTKVIHYK PISINYRTEI
3D Structure
Computationally Modelled Structure
Click to Save PDB File
Protein Scaffold Information of This SBP
Scaffold ID PS047
Scaffold Info
[1] , [2]
Scaffold Name Monobody
Scaffold Class Non-Antibody
Fold Type Beta-Sheets + Loops
Binding Target(s) of This SBP (BTS)
BTS Name Details Mechanism Application Affinity Research Organization Ref
Growth/differentiation factor 8
BTS Info
Inhibitor Duchenne muscular dystrophy [ICD-11: 8C70.1]; Cachexia [ICD-11: MG20.Z] Kd: 0.17 nM Bristol-Meyers Squibb; Roche [1] , [2]
Clinical Trial Information of This SBP
EUCTR2016-001654-18-BE Click to show the Detail
Indication Duchenne Muscular dystrophy
Phase Phase III
Title A randomized, double blind, placebo-controlled, study to assess the efficacy, safety, and tolerability of RO7239361 (BMS-986089) in ambulatory boys with Duchenne Muscular dystrophy
Status Not Recruiting
Sponsor F. Hoffmann-La Roche Ltd
EUCTR2016-001654-18-DE Click to show the Detail
Indication Duchenne Muscular dystrophy
Phase Phase III
Title A randomized, double blind, placebo-controlled, study to assess the efficacy, safety, and tolerability of RO7239361 in ambulatory boys with Duchenne Muscular dystrophy
Status Not Recruiting
Sponsor F. Hoffmann-La Roche Ltd
EUCTR2016-001654-18-ES Click to show the Detail
Indication Duchenne Muscular Dystrophy
Phase Phase III
Title A Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys with Duchenne Muscular Dystrophy
Status Not Recruiting
Sponsor F. Hoffmann-La Roche Ltd
EUCTR2016-001654-18-FR Click to show the Detail
Indication Duchenne Muscular dystrophy
Phase Phase III
Title A Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys with Duchenne Muscular Dystrophy
Status Not Recruiting
Sponsor F. Hoffmann-La Roche Ltd
EUCTR2016-001654-18-GB Click to show the Detail
Indication Duchenne Muscular dystrophy
Phase Phase III
Title A Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys with Duchenne Muscular Dystrophy
Status Not Recruiting
Sponsor F. Hoffmann-La Roche Ltd
EUCTR2016-001654-18-IT Click to show the Detail
Indication Duchenne Muscular Dystrophy
Phase Phase III
Title A Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys with Duchenne Muscular Dystrophy
Status Authorised
Sponsor F. Hoffmann-La Roche Ltd
EUCTR2016-001654-18-NL Click to show the Detail
Indication Duchenne Muscular Dystrophy
Phase Phase III
Title A Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys with Duchenne Muscular Dystrophy
Status Authorised
Sponsor F. Hoffmann-La Roche Ltd
EUCTR2016-001654-18-SE Click to show the Detail
Indication Duchenne Muscular dystrophy
Phase Phase III
Title A randomized, double blind, placebo-controlled, study to assess the efficacy, safety, and tolerability of RO7239361 in ambulatory boys with Duchenne Muscular dystrophy
Status Not Recruiting
Sponsor F. Hoffmann-La Roche Ltd
NCT02145234 Click to show the Detail
Indication Healthy
Phase Phase I
Title A Randomized, Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects
Status Completed
Sponsor Hoffmann-La Roche
NCT02515669 Click to show the Detail
Indication Duchenne Muscular Dystrophy
Phase Phase I; Phase II
Title A Multi-Site, Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7239361 (BMS-986089) in Ambulatory Boys With Duchenne Muscular Dystrophy
Status Terminated
Sponsor Hoffmann-La Roche
NCT03039686 Click to show the Detail
Indication Duchenne Muscular Dystrophy
Phase Phase II; Phase III
Title Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular Dystrophy
Status Completed
Sponsor Hoffmann-La Roche
NCT05337553 Click to show the Detail
Indication Spinal Muscular Atrophy; Neuromuscular Diseases; SMA
Phase Phase III
Title A Study to Evaluate the Efficacy and Safety of Taldefgrobep Alfa in Participants With Spinal Muscular Atrophy
Status Active, not recruiting
Sponsor Biohaven Pharmaceuticals, Inc.
References
1 In vitro-engineered non-antibody protein therapeutics. Protein Cell. 2018 Jan;9(1):3-14.
2 DRUGBANK online. Talditercept alfa